CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children

Inclusion criteria

• Ages 24 months to 55 years old at the time of enrollment
• Diagnosed with DRE: not achieved seizure freedom, with adequate trials of 2 antiseizure medications 29
• Medical history of 4 + clinically recognizable seizures (any type with clusters counted as a single event) per month
• Have a negative pregnancy test at screening for patients who have experienced menarche
• Agree to abstain from driving and recreational cannabis use throughout the study

Exclusion criteria

• Diagnosis of psychogenic non-epileptic seizure
• Recent (<30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator
• Ketogenic diet started within 6 months (participants stable on the ketogenic diet for more than 6 months are eligible to participate)
• Vagal nerve stimulator implanted and activated within 12 months
• Concomitant regular use of narcotics (except in emergencies and physician supervised)
• Initiation or dosage change of oral or injected steroids within 3 months
• Allergy or intolerance to compounds in trial preparations
• DRE secondary to progressive neurological disease
• Clinically significant cardiac, renal or hepatic disease (as assessed by site investigator); elevated liver enzymes (GGT and/or AST and/or ALT) or lipase >3 times upper limit, adjusted for age
• History of psychotic disorders
• Uncontrolled (in the perspective of the qualified investigator) medical conditions including substance use disorders
• History or concurrent cannabis use disorder
• Unwilling or unable to use highly effective methods of contraception throughout the study period and three months post-trial, where applicable